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ASTM E2182-02

(Specification)

Standard Specification for Clinical XML DTDs in Healthcare (Withdrawn 2011)

Standard Specification for Clinical XML DTDs in Healthcare (Withdrawn 2011)

ABSTRACT
This specification defines an electronic representation that includes the varying information required for broad exchange in health care both today and in the future. eXtensible Markup Language (XML) is a convergence of data processing, communication, and publishing technology. XML is a platform, vendor, and application independent technology for describing document content and structure in tags or elements. The names of the tags and the rules for using them are contained in the document type definition (DTD). The clinical XML DTD defines the standard XML DTD for: admission notes, discharge summaries, history and physical examinations, operative reports, pathology reports, radiology reports, and radiation therapy summaries. The DTDs define templates for clinical content. Clinical content may take the form of character data or elements from the XHTML Basic 1.0 DTD.
SCOPE
1.1 This specification defines an electronic representation that includes the varying information required for broad exchange in health care both today and in the future. eXtensible Markup Language (XML) is a convergence of data processing, communication, and publishing technology. XML is a platform, vendor, and application independent technology for describing document content and structure in tags or elements. The names of the tags and the rules for using them are contained in the Document Type Definition (DTD). The DTD describes the structure of the document and defines the names of tags it contains. Additionally the DTD declares the order in which the tags occur and how often the tags can appear; that is, the DTD defines the hierarchy of the tags. A DTD for a prescription might contain structural elements for the medication prescribed medication>, the dosage dosage>, the form form>, the quantity quantity>, and so forth. This specification is in the form of a set of standard XML DTDs that match the electronic document requirements in the health care industry.
1.2 This specification refers to and makes use of recommendations from the World Wide Web consortium, the W3C (http://www.w3.org).
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.
WITHDRAWN RATIONALE
Formerly under the jurisdiction of Committee E31 on Healthcare Informatics, this Specification was withdrawn in 2011 in accordance with section 10.5.3.1 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.

General Information

Status
Withdrawn
Publication Date
09-Jan-2002
Withdrawal Date
31-Dec-2010
ICS
35.240.80 - IT applications in health care technology
Technical Committee
E31 - Healthcare Informatics
Drafting Committee
E31.25 - Healthcare Data Management, Security, Confidentiality, and Privacy
Current Stage
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ASTM E2182-02 - Standard Specification for Clinical XML DTDs in Healthcare (Withdrawn 2011)ASTM E2182-02 - Standard Specification for Clinical XML DTDs in Healthcare (Withdrawn 2011)
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ASTM E2182-02 - Standard Specification for Clinical XML DTDs in Healthcare (Withdrawn 2011)
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
An American National Standard
Designation: E2182 – 02
Standard Specification for
1
Clinical XML DTDs in Healthcare
This standard is issued under the fixed designation E2182; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope E1633 Specification for Coded Values Used in the Elec-
2
tronic Health Record
1.1 This specification defines an electronic representation
E2183 Guide for XML DTD Design, Architecture and
that includes the varying information required for broad
Implementation
exchange in health care both today and in the future. eXten-
2.2 W3C World Wide Web Consortium Recommendations,
sible Markup Language (XML) is a convergence of data
(http://www.w3.org)
processing, communication, and publishing technology. XML
XML 1.0 Recommendation, http://www.w3.org/TR/REC-
is a platform, vendor, and application independent technology
xml
for describing document content and structure in tags or
XHTML Basic Recommendation, http://www.w3.org/TR/
elements. The names of the tags and the rules for using them
xhtml-basic
are contained in the Document Type Definition (DTD). The
XML Linking (Xlink) 1.0 Recommendation, http://
DTD describes the structure of the document and defines the
www.w3.org/TR/xlink
names of tags it contains. Additionally the DTD declares the
XML Namespaces Recommendation, http://www.w3.org/
order in which the tags occur and how often the tags can
TR/REC-xml-names
appear; that is, the DTD defines the hierarchy of the tags. A
XPointer, http://www.w3.org/TR/xptr
DTD for a prescription might contain structural elements for
XSLT, http://www.w3.org/TR/xslt
themedicationprescribed,thedosage,
2.3 HL7 Standards, (http://www.HL7.org)
the form , the quantity , and so forth. This
Informative Document: Using XML as anAlternative Mes-
specificationisintheformofasetofstandardXMLDTDsthat
sage Syntax for HL7 Version 2.3.x
match the electronic document requirements in the health care
Clinical Document Architecture: Level 1
industry.
2.4 IETF Specifications, (http://www.ietf.org)
1.2 This specification refers to and makes use of recommen-
RFC 2396: Uniform Resource Indentifiers (URI), http://
dations from the World Wide Web consortium, the W3C
ietf.org/rfc/rfc2396
(http://www.w3.org).
1.3 This standard does not purport to address all of the
3. Terminology
safety concerns, if any, associated with its use. It is the
3.1 Definitions:
responsibility of the user of this standard to establish appro-
3.1.1 clinical document, n—defined in terms of the native
priate safety and health practices and determine the applica-
XML architecture. The Document Type Definition (DTD) is
bility of regulatory requirements prior to use.
the base method of defining the structure of a clinical docu-
2. Referenced Documents ment. XMLschema languages such as the W3C XMLSchema
2
Language and the OASIS RELAXNG Schema language pro-
2.1 ASTM Standards:
vide alternative methods of defining clinical document struc-
E1239 PracticeforDescriptionofReservation/Registration-
tures.
Admission, Discharge, Transfer (R-ADT) Systems for
2
3.1.2 document type definition (DTD), n—the formal defi-
Electronic Health Record (EHR) Systems
nition of the elements, structures, and rules for enabling
E1384 Practice for Content and Structure of the Electronic
2
platform independent data access via XML or for marking up
Health Record (EHR)
a given type of SGML document.
3.1.3 extensible markup language (XML), n—a standard
1
fromtheWorldWideWebConsortium(W3C)thatprovidesfor
This specification is under the jurisdiction of ASTM Committee E31 on
Healthcare Informatics and is the direct responsibility of Subcommittee E31.25 on
tagging of information content within documents, offering a
Healthcare Data Management, Security, Confidentiality, and Privacy.
means for representation of content in a format which is both
Current edition approved July 17, 2006. Published March 2002. DOI: 10.1520/
human and machine readable.Through the use of customizable
E2182-02.
2
Annual Book of ASTM Standards, Vol 14.01. style sheets and schemas, information can be represented in a
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
E2182 – 02
uniform way, allowing for interchange of both content (data) 3.1.11 URI—identifies a Web resource according to IETF
and format (metadata). RFC2396.Usedinpracticetoformlinksbetween,tonameand
to locate web documents. Also used to name XML
3.1.4 Health Level 7 (HL7), n—a standards organization
namespaces.
traditi
...

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SIGNIFICANCE AND USE
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ASTM E2147-01(2013)(Specification)
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ABSTRACT
This specification describes the security requirements involved in the development and implementation of audit and disclosure logs used in health information systems. It specifies how to design an access audit log to record all access to patient identifiable information maintained in computer systems, and includes principles for developing policies, procedures, and functions of health information logs to document all disclosure of confidential health care information to external users for use in manual and computer systems. This specification provides for two main purposes, namely: to define the nature, role, and function of system access audit logs and their use in health information systems as a technical and procedural tool to help provide security oversight; and to identify principles for establishing a permanent record of disclosure of health information to external users and the data to be recorded in maintaining it.
SIGNIFICANCE AND USE
4.1 Data that document health services in health care organizations are business records and must be archived to a secondary but retrievable medium. Audit logs should be retained, at a minimum, according to the statute governing medical records in the geographic area.  
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ASTM E1869-04(2010)(Guide)
Standard Guide for Confidentiality, Privacy, Access, and Data Security Principles for Health Information Including Electronic Health Records

SIGNIFICANCE AND USE
Many U.S. healthcare and health information systems leaders believe that electronic health information systems that include computer-based patient records will improve health care. To achieve this goal these systems will need to protect individual privacy of patient data, provide appropriate access, and use adequate data security measures. Sound information policies and practices must be in place prior to the wide-scale deployment of health information systems. Strong enforceable privacy policies must shape the development and implementation of these systems.
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Standard Guide for Information Access Privileges to Health Information

SIGNIFICANCE AND USE
The maintenance of confidentiality in paper-based, electronic, or computer-based health information requires that policies and procedures be in place to protect confidentiality. Confidentiality of information depends on structural and explicit mechanisms to allow persons or systems to define who has access to what, and in what situation that access is granted. For guidelines on the development and implementation of privilege management infrastructures supporting these mechanisms, see Guide E2595.
Confidential protection of data elements is a specific requirement. The classification of data elements into restrictive and specifically controlled categories is set by policies, professional practice, and laws, legislation, and regulations.
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1.1 This guide covers the process of granting and maintaining access privileges to health information. It directly addresses the maintenance of confidentiality of personal, provider, and organizational data in the healthcare domain. It addresses a wide range of data and data elements not all traditionally defined as healthcare data, but all elemental in the provision of data management, data services, and administrative and clinical healthcare services. In addition, this guide addresses specific requirements for granting access privileges to patient-specific health information during health emergencies.
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ABSTRACT
This specification describes the security requirements involved in the development and implementation of audit and disclosure logs used in health information systems. It specifies how to design an access audit log to record all access to patient identifiable information maintained in computer systems, and includes principles for developing policies, procedures, and functions of health information logs to document all disclosure of confidential health care information to external users for use in manual and computer systems. This specification provides for two main purposes, namely: to define the nature, role, and function of system access audit logs and their use in health information systems as a technical and procedural tool to help provide security oversight; and to identify principles for establishing a permanent record of disclosure of health information to external users and the data to be recorded in maintaining it.
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Data that document health services in health care organizations are business records and must be archived to a secondary but retrievable medium. Audit logs should be retained, at a minimum, according to the statute governing medical records in the geographic area.
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Standard Guide for Electronic Authentication of Health Care Information

SIGNIFICANCE AND USE
This guide serves three purposes:
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SCOPE
1.1 This guide covers:
1.1.1 Defining a document structure for use by electronic signature mechanisms (Section 4),
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1.1.3 Defining minimum requirements for different electronic signature mechanisms (Section 5),
1.1.4 Defining signature attributes for use with electronic signature mechanisms (Section 6),
1.1.5 Describing acceptable electronic signature mechanisms and technologies (Section 7),
1.1.6 Defining minimum requirements for user identification, access control, and other security requirements for electronic signatures (Section 9), and
1.1.7 Outlining technical details for all electronic signature mechanisms in sufficient detail to allow interoperability between systems supporting the same signature mechanism (Section 8 and Appendix X1-Appendix X4).
1.2 This guide is intended to be complementary to standards under development in other organizations. The determination of which documents require signatures is out of scope, since it is a matter addressed by law, regulation, accreditation standards, and an organization's policy.
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ASTM E1715-01(2008)(Practice)
Standard Practice for An Object-Oriented Model for Registration, Admitting, Discharge, and Transfer (RADT) Functions in Computer-Based Patient Record Systems

SIGNIFICANCE AND USE
RADT Object Model as a Basis for Communication—The RADT object model is the first model used to create a common library of consistent entities (objects) and their attributes in the terminology of object analytical models as applied to the healthcare domain. These object models can be used to construct and refine standards relating to healt care information and its management. Since the RADT object model underpins the design and implementation of specific systems, it provides the framework for establishing the systematics of managing observations made during health care. The observations recorded during health care not only become the basis for managing an individual's health care by practitioners but are also used for research and resource management. They define the common language for abstracting and codifying observations. The inconsistency and incompleteness of the data recorded in paper records is well known and has been noted by the Institute of Medicine's study (4). The ability to build the recommended EHR begins with RADT, as noted in Practice E 1239. A more detailed specification of the RADT process and its specific functional domain shall begin with a formal model. Furthermore, following agreement on the initial model, that model shall evolve as knowledge accumulates and the initial view of the healthcare domain extends to other social and psychologic processes that link healthcare with other functional domains of society. The management of lifelong cases of care, such as those of birth defects in newborns, will involve interactions with social work and educational functional domains of experience. It has been recognized for some time (5) that a “healthcare team,” in the broader sense, is involved in dealing with these complex cases. The RADT model is the core to linking these functional domains together in a transparent way. For that reason, the object terminology is used to enable the most global view and vernacular that will facilitate communication amo...
SCOPE
1.1 This practice is intended to amplify Practice E 1239 and to complement Practice E 1384 by detailing the objects that make up the reservation, registration, admitting, discharge, and transfer (RADT) functional domain of the computer-based record of care (CPR). As identified in Practice E 1239, this domain is seminal to all patient record and ancillary system functions, including messaging functions used in telecommunications. For example, it is applicable to clinical laboratory information management systems, pharmacy information management systems, and radiology, or other image management, information management systems. The object model terminology is used to be compatible with other national and international standards for healthcare data and information systems engineering or telecommunications standards applied to healthcare data or systems. This practice is intended for those familiar with modeling concepts, system design, and implementation. It is not intended for the general computer user or as an initial introduction to the concepts.

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ASTM E2171-02(2008)(Practice)
Standard Practice for Rating-Scale Measures Relevant to the Electronic Health Record

SIGNIFICANCE AND USE
The simplicity and practicality of Rasch's probabilistic scale-free measurement models have brought within reach universal metrics for educational and psychological tests, and for rating scale-based instruments in general. There are at least 3 implications to the application of Rasch's models to the health-related calibration of universal metrics for each of the variables relevant to the Electronic Health Record (EHR) that are typically measured using rating scale instruments.
First, establishing a single metric standard with a defined range and unit will arrest the burgeoning proliferation of new scale-dependent metrics.
Second, the communication of the information pertaining to patient status represented by these measures (physical, cognitive, and psychosocial health status, quality of life, satisfaction with services, etc.) will be simplified.
Third, common standards of data quality will be used to evaluate and improve instrument performance. The vast majority of test and survey data quality is currently almost completely unknown, and when quality is evaluated, it is via many different methods that are often insufficient to the task, misapplied, misinterpreted, or even contradictory in their aims.
Fourth, currently unavailable economic benefits will accrue from the implementation of measurement methods based on quality-assessed data and widely accepted reference standard metrics. The potential magnitude of these benefits can be seen in an assessment of 12 different metrological improvement studies conducted by the National Science and Technology Council (Subcommittee on Research, 1996). The average return on investment associated with these twelve studies was 147 %. Is there any reason to suppose that similar instrument improvement efforts in the psychosocial sciences will result in markedly lower returns?
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SCOPE
1.1 This standard addresses the identification of data elements from the EHR definitions in Practice E 1384 that have ordinal scale value sets and which can be further defined to have scale-free measurement properties. It is applicable to data recorded for the Electronic Health Record and its paper counterparts. It is also applicable to abstracted data from the patient record that originates from these same data elements. It is applicable to identifying the location within the EHR where the observed measurements shall be stored and what is the meaning of the stored data. It does not address either the uses or the interpretations of the stored measurements.

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ASTM E2553-07(Guide)
Standard Guide for Implementation of a Voluntary Universal Healthcare Identification System

SCOPE
1.1 This document describes the implementation principles needed to create a Voluntary Universal Healthcare Identification (VUHID) system. The purpose of this system is to enable unambiguous identification of individuals in order to facilitate the delivery of healthcare.
1.2 The VUHID system should be dedicated exclusively to the needs and functions of healthcare.
1.3 The VUHID system is designed to represent no, or at least minimal, increased risk to healthcare privacy and security.
1.4 The system should be as cost-effective as possible.
1.5 The system must be created and maintained in a way to provide sustained benefit to healthcare.
1.6 The system should be designed and implemented in a manner that ensures that it can operate indefinitely.
This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

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ASTM E2457-07(Terminology)
Standard Terminology for Healthcare Informatics

SCOPE
1.1 This terminology is intended to name and document the principal concepts, and their associated terms, that are utilized in the healthcare information domain and all of its specialized subdomains. It is applicable to all areas of healthcare about which information is kept or utilized. It is intended to complement and utilize those concepts already identified by other national and international standards bodies. It will identify alternate accepted terms for the same concept and its elected term. Its terms are intended to clarify and simplify usage in the dialog and documentation about the concepts, processes and data that are used to schedule, conduct and manage all phases of healthcare. This common usage will improve the quality and management of all facets of healthcare by means of explicit information used in referring to each of these facets. These health informatics terms have been collected here specifically in order to facilitate the consistent use of common concepts in informatics standards development and use throughout healthcare. A separate process from this standard that is described in ISO 15188 will manage the approval of biomedical and healthcare terms.
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